The Manager/Sr. Manager, will represent Nonclinical Writing on project teams, working directly with scientists within the Early Development (eDEV) and Research departments and collaboratively with Clinical, Medical Writing, Pharmacovigilance, and Regulatory Affairs and Operations functions to lead the preparation of high-quality submission content for nonclinical summary document sections in support of global regulatory filings.

Summary of Key Responsibilities:

Lead nonclinical writing assignments in conjunction with scientists and project team members for early development/late stage programs in the preparation of nonclinical content in support of regulatory submissions (eg, nonclinical protocols and reports, Investigator’s Brochures, Briefing Documents, INDs, IMPDs, annual reports/DSURs, NDA/MAAs).

Bachelor's degree in Life Sciences with 4+ years’ experience in relevant field. Professional certification/credentials, experience with regulatory submissions is a plus.

In-depth knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and the drug development process.

Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.

Impeccable attention to detail and excellent written and oral communication skills.

Must be proficient in Microsoft® Suite (Word, Excel, PowerPoint, Visio). Experience with electronic document management and tracking systems a plus.

Internal Number: ED18R0001

About Alnylam Pharmaceuticals Inc.

Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our “Alnylam 2020” guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, and 2017.